Skylark Device Co., Ltd.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K990233	ST-302 INFRAREX	ILY	1999-10-27	View
510(k)	K984506	SD-100 SKYEAR THERMOMETER	FLL	1999-07-29	View
510(k)	K981449	SD-956 ULTRASOUND THERAPY	IMI	1998-12-11	View
510(k)	K983964	BATCH #6060 CONDUCTIVE GEL	GYB	1998-12-09	View
510(k)	K964437	GB-1002 TENS WITH MASSAGE	GZJ	1998-08-14	View
510(k)	K974585	IF-727 INTERFERENTIAL STIMULATOR	LIH	1998-03-06	View
510(k)	K964434	SD-970EMS ELECTRICAL MUSCULAR STIMULATOR	IPF	1997-10-09	View
510(k)	K963729	SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)	GZJ	1997-02-13	View
510(k)	K946337	IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II	EGJ	1995-12-20	View
510(k)	K946299	PGS123 AND HVS-123	GZJ	1995-06-26	View
510(k)	K934051	BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)	GZJ	1994-07-11	View
510(k)	K930535	IF400	LIH	1994-06-14	View
510(k)	K931079	STAT-TENS	GZJ	1994-06-09	View
510(k)	K925729	SD-602 SD MODE 11, SD-603 SD MOD 111	GZJ	1993-01-22	View
510(k)	K923934	TX-3 SD	GZJ	1992-10-23	View
510(k)	K923935	SD-605 SD II PROGRAM	GZJ	1992-10-15	View
510(k)	K923298	MICRO 100,200,300, & 400 TENS	GZJ	1992-10-13	View
510(k)	K912643	ELECTRODE	GXY	1992-02-14	View
510(k)	K912642	EMS300, EMS400, EMS8000	IPF	1991-12-09	View
510(k)	K912178	BIO TENS 601, 606 AND 608 (3000)	GZJ	1991-10-25	View